Spasmomen somatico

Patient Information Leaflet: Information for the User

SPASMOMEN SOMATIC 40 mg + 2 mg coated tablets

Otilonium bromide + diazepam
Please read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What SPASMOMEN SOMATIC is and what it is used for
2. What you need to know before taking SPASMOMEN SOMATIC
3. How to take SPASMOMEN SOMATIC
4. Possible side effects
5. How to store SPASMOMEN SOMATIC
6. Contents of the pack and other information

1. What SPASMOMEN SOMATICO is and what it is used for

SPASMOMEN SOMATICO contains the active substances otilonium bromide, a compound with spasmolytic action (i.e., induces relaxation) on the smooth muscle of the gastrointestinal tract, and diazepam, a benzodiazepine with anxiolytic action (reduces anxiety).
SPASMOMEN SOMATICO is used in adults for the treatment of spastic-painful manifestations (strong contractions of the muscles associated with pain) with an anxious component affecting the gastrointestinal system.

2. What you need to know before taking SPASMOMEN SOMATICO

Do not take SPASMOMEN SOMATICO

• If you are allergic to the active substances (oatilonium bromide, diazepam) or to any of the other ingredients of this medicine (listed in section 6);
• if you have glaucoma (increased internal pressure of the eye);
• in case of prostatic hypertrophy (enlargement of the prostate);
• in case of intestinal obstruction syndromes (arrest of intestinal content progression due to the presence of an obstacle or blockage) or urinary retention (inability of the bladder to expel urine);
• in case of severe myasthenia (a disease characterized by muscle weakness).

The use of SPASMOMEN SOMATICO is contraindicated during the first trimester of pregnancy (see "Pregnancy and breastfeeding").
Furthermore, it is not recommended in early infancy (see "Children and adolescents").
Warnings and precautions
Talk to your doctor or pharmacist before taking SPASMOMEN SOMATICO.
If you take SPASMOMEN SOMATICO for a prolonged period, it is advisable to carry out regular blood tests and liver function tests.
In predisposed individuals, treatment with benzodiazepines at high doses and for prolonged periods may lead to dependence, as occurs with other medicines having hypnotic (sleep-inducing), sedative (calming), and ataractic (tranquillizing) effects.
Since individual responsiveness (personal response to the drug) varies greatly, if you are elderly or debilitated, the dose of SPASMOMEN SOMATICO should be determined cautiously (see section 3 "How to take SPASMOMEN SOMATICO").
Children and adolescents
SPASMOMEN SOMATICO contains otilonium bromide and diazepam, a benzodiazepine with anxiolytic action. The use of benzodiazepines in early infancy is generally not recommended (see "Do not take SPASMOMEN SOMATICO").
Other medicines and SPASMOMEN SOMATICO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Concomitant use of SPASMOMEN SOMATICO and other psychotropic drugs requires special caution and medical supervision to avoid unexpected adverse effects due to interactions.
Use SPASMOMEN SOMATICO with caution when combined with centrally-acting medicines (those acting on the central nervous system), such as neuroleptics (antipsychotic drugs used to treat certain psychiatric conditions such as schizophrenia, bipolar disorder, and some forms of depression), antidepressants, hypnotics (drugs that induce sleep), analgesics (reduce pain), and anesthetics (drugs capable of inducing temporary loss of pain sensation), as this combination may increase sedative effects.
The concomitant use of Spasmomen Somatico and opioids (substances used as strong painkillers, for substitution therapy in drug-dependent patients, and present in some cough medicines) increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Spasmomen Somatico together with opioids, the dose and duration of concomitant treatment must be limited by the doctor.
Inform your doctor about all opioid medicines you are taking and carefully follow the doctor's instructions regarding dosage. It may be helpful to inform family members and friends about how to recognize the signs and symptoms described above. If you experience such symptoms, contact your doctor.
SPASMOMEN SOMATICO and alcohol
Do not consume alcoholic beverages during treatment with SPASMOMEN SOMATICO, as individual reactions are unpredictable, just as with any other psychotropic medicine (affecting mental state).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take SPASMOMEN SOMATICO during the first trimester of pregnancy (see "Do not take SPASMOMEN SOMATICO").
During the second and third trimesters of pregnancy, take SPASMOMEN SOMATICO only if clearly needed and when, in the doctor's judgment, potential benefits outweigh possible risks.
Breastfeeding
If you are breastfeeding, take SPASMOMEN SOMATICO only if clearly needed and when, in the doctor's judgment, potential benefits outweigh possible risks.
Driving and using machines
SPASMOMEN SOMATICO, like other medicines in the same therapeutic class, depending on the method of use, dosage, and individual sensitivity, may affect reaction ability (e.g., fitness to drive a vehicle, behavior during road traffic, operation of machinery requiring particular attention).

3. How to take SPASMOMEN SOMATICO

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1–3 tablets daily, according to the doctor's judgment, preferably taken after meals.
However, the choice of the most appropriate dosage should be guided by the characteristics of the fixed combination (otilonium bromide + diazepam), rather than by those of the individual components.
In elderly patients, dosage must be carefully determined by the doctor, who should consider a possible reduction of the above-mentioned doses (see "Warnings and precautions").
If you take more SPASMOMEN SOMATICO than you should
In animals, otilonium bromide has proven practically devoid of toxicity. Consequently, in humans, no particular problems due to overdose are expected.
Symptoms of diazepam overdose include drowsiness, confusion, coma, and reduced reflexes. Although these effects are generally minimal, breathing, pulse (heart rate), and blood pressure should be monitored, and general supportive measures should be implemented together with immediate gastric lavage (emptying of the stomach).
If you forget to take SPASMOMEN SOMATICO
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of SPASMOMEN SOMATICO:
Rare side effects:

• ataxia (impaired muscle coordination making it difficult to perform certain movements);
• headache;
• nausea, vomiting, diarrhoea, constipation, abdominal pain;
• palpitations (increased awareness of heartbeat);
• visual disturbances;
• hypotension (low blood pressure);
• dry mouth;
• itching, skin rashes (appearance of red, more or less raised spots on the skin);
• sialorrhoea (excessive saliva production);
• depression, confusion, hallucinations;
• cases of granulocytopenia (decreased concentration of granulocytes, a type of white blood cells, in the blood);
• changes in blood levels (concentration in the blood) of transaminases (enzymes whose blood concentration indicates the presence of liver diseases), phosphatase (enzyme providing information on possible diseases of the bones, liver, pancreas and intestine), and bilirubin (a coloured substance present in bile derived from haemoglobin degradation);
• irritability.

Side effects with frequency not known (frequency cannot be estimated from the available data):

• somnolence;
• dizziness.

These side effects are more frequent in elderly or debilitated patients.
If these are signs of relative overdose (a condition where the drug is taken according to the recommended dosage, but due to, for example, liver or kidney diseases, its blood concentration increases), they disappear spontaneously within a few days or after adjustment of the dosage.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SPASMOMEN SOMATIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after 'Exp'. The expiry date refers to the last day of that month and to the product in its original, unopened packaging stored correctly.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SPASMOMEN SOMATICO contains
Each coated tablet contains:
Active substances: otilonium bromide 40 mg, diazepam 2 mg.
Other components: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, precipitated silica, magnesium stearate, hypromellose, titanium dioxide, talc, polyethylene glycol, iron oxides.

Description of the appearance of SPASMOMEN SOMATICO and pack contents
Oblong, pinkish coated tablets.
Blister pack containing 30 coated tablets in a cardboard box.

Marketing Authorization Holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l., via Sette Santi, 3 - Florence.

Manufacturer
A. Menarini Manufacturing Logistics and Services s.r.l. - Via Sette Santi, 3 - Florence.
Berlin Chemie AG – Glienicker Weg, 125 - Berlin (Germany).
A. Menarini Manufacturing Logistics and Services s.r.l. – Campo di Pile – L’Aquila.